Appeals court reverses J&J decision

FDA's chief litigator said he is focusing on corporate chief executives for personal prosecution in cases of flagrant off-label product promotions. Agency deputy chief counsel for litigation Eric M. Blumberg told a Food & Drug Law Institute Enforcement and Litigation Conference in October that this area is a top priority under a rejuvenated strategy using the Park Doctrine, which holds CEOs liable even when they knew nothing about the offenses.
A West Virginia appeals court has reversed a lower court ruling and $4.5 million penalty against Johnson & Johnson for having allegedly made misleading statements in communications to doctors on its antipsychotic drug Risperdal and Duragesic fentanyl patch. The penalty was applied to a 2003 Janssen letter to doctors on Risperdal and a 2003 14-page promotional file card on Duragesic. The appeals court found that the lower court erred when it relied on a CDER Division of Drug Marketing, Advertising and Communications Warning Letter as evidence the communications were false and misleading. Because Warning Letters do not constitute “final agency action,” they are not susceptible to judicial review, the appeals court said.
“Accordingly, the circuit court erred in giving preclusive effect to the FDA's determinations that Janssen had violated the FDCA through its statements and omissions” in the Risperdal and Duragesic communications.

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